ConnectDX

Respiratory Infectious Diseases

P sychiatry pharmacogenetics laboratory testing Urine Toxicology ORAL TOXICOLOGY

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CONTENTS TABLE OF 06 10 PG. 06 Connect DX Toxicology

12 14 16 20 22

Urine Toxicology

CLIA & CAP Accredited

Oral Toxicology

Infectious Diseases

Respiratory Infectious Disease Testing

CALL US: (800) 450-0040 OuR address: 236 W. Edison Rd, Mishawaka, IN 46545

ABOUT CONNECTDX LABORATORIES

PG. 26

26 30 34 36 40 42

COVID-19 Testing (PCR)

Infectious Disease Testing in Women

UTI Testing

Cardiovascular Pharmacogenetics Testing

Psychiatry Pharmacogenetics Lab Testing

Our Goal & Mission

T ransforming C linical A ssessments I nto A ctionable I nsight Committed to improving healthcare through advanced precision diagnostics, infectious disease testing, and prescription drug monitoring.

COVID-19 TESTING ( PCR)

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LEARN MORE ABOUT AND THE WE OFFER. ConnectDx SERVICES

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L ocated in the South Bend area of Indiana, ConnectDx Laboratories is a medical laboratory testing facility accredited under CLIA and CAP. At ConnectDx Laboratories, we provide advanced diagnostic testing for healthcare providers, medical facilities and homecare agencies. Our mission is to offer superior and innovative testing services that meet the needs of the providers in our communities, while leading the way for operational excellence through honesty and integrity. It is our goal to be a trusted resource for healthcare providers and offer testing solutions that improve patient outcomes. CONTACT US TODAY: 236 W. Edison Rd Mishawaka, IN 46545 (800) 450-0040

At ConnectDx Labs, we know you have many options to choose from. To set ourselves apart, we strive to be a single source provider for your clinical needs. From quick turn-around time to unparalleled customer service, it is our goal to be your trusted laboratory partner for the patients or residents that you serve on a daily basis. We offer testing solutions for toxicology (oral/urine), infectious diseases and pharmacogenetics. Under the oversight of our leadership team, our highly skilled technicians operate in a modern digital lab to handle everything from carrying out routine diagnostic tests and screenings, to providing an accurate and valuable result to assist you in creating treatment plans for complex illnesses.

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W e provide advanced diagnostic testing for • healthcare providers • medical facilities • homecare agencies

CONNECTDXLABS.COM 236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

T oxicology is the scientific discipline that studies the adverse effects of chemicals, drugs, and other substances on living organisms. It involves the identification, characterization, and evaluation of toxic substances and their mechanisms of action, as well as the assessment of their potential risks to human health and the environment. Toxicologists examine how various substances interact with biological systems, including cells, tissues, organs, and whole organisms. They investigate the toxic effects of chemicals at different levels, such as molecular, cellular, and systemic, to understand their modes of toxicity. These effects can range from immediate reactions to chronic conditions, and toxicologists aim to determine the dose-response relationship—the relationship between the

amount of exposure to a substance and the resulting toxic effects. The field of toxicology is interdisciplinary and incorporates knowledge from biology, chemistry, pharmacology, biochemistry, physiology, and environmental science. Toxicologists employ a variety of experimental and computational methods to assess the toxicity of substances, including in vitro studies using cells and tissues, animal testing, and epidemiological studies of human populations. Toxicology plays a crucial role in various areas, including drug development, chemical safety evaluation, environmental risk assessment, occupational health, forensic toxicology, and public health. CONTINUE READING > > >

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Toxicologists valuable information for regulatory agencies, industries, healthcare professionals, and policymakers to make informed decisions regarding the use, regulation, and management of potentially harmful substances. It's important to note that the provide field of toxicology adheres to ethical principles and guidelines to ensure the humane treatment of animals and the responsible use of scientific methods. In recent years, efforts have been made to develop alternative testing methods that reduce reliance on animal models and promote more predictive and efficient toxicological assessments.

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

U rine toxicology, also known as urine drug testing, is a common method used to detect the presence of drugs or their metabolites in a person's urine. It is widely employed in various settings, including healthcare, workplace monitoring, forensic investigations, and substance abuse treatment programs. Urine Toxicology

Urine drug tests are conducted by collecting a urine sample from an individual and analyzing it to identify the presence of specific drugs or drug metabolites. The test can detect a wide range of substances, including illicit drugs (such as marijuana, cocaine, opioids, amphetamines), prescription medications (such as benzodiazepines, opioids), and other substances of abuse. The process typically involves the following steps: 1. Sample collection: The individual provides a urine sample under supervised conditions to ensure sample integrity and prevent tampering. 2. Sample analysis: The urine sample is sent to a laboratory or analyzed using point-of-care testing devices. Various techniques 2. 1.

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may be employed, such as immunoassays, gas chromatography-mass spectrometry (GC-MS), or liquid chromatography-mass spectrometry (LC-MS). 3. Interpretation of results: The presence or absence of specific drugs or drug metabolites is determined based on predetermined cutoff levels. If a drug or its metabolite exceeds the cutoff concentration, it is considered a positive result. It's important to note that urine drug 3. tests have limitations. They provide information about recent drug use rather than long-term drug history. The detection window for different drugs varies depending on factors such as drug

potency, frequency of use, metabolism, and individual variations. Some drugs may be detected for only a few hours after use, while others can be detected for several days or even weeks. Urine toxicology is a valuable tool in various contexts, including clinical settings for monitoring medication adherence, workplace drug testing to ensure safety and productivity, and forensic investigations to determine drug use in legal cases. It can also be an essential component of substance abuse treatment programs, helping to monitor abstinence and support recovery efforts.

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

L ocated in the South Bend area of Indiana, ConnectDx Laboratories is a medical laboratory testing facility accredited under CLIA and CAP. Being CLIA and CAP accredited refers to the compliance of a laboratory with certain regulatory and quality standards set by two prominent organizations in the United States: the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) .

ORAL TOXICOLOGY

O ral toxicology, also referred to as oral toxicity testing or oral toxicological assessment, involves the evaluation of the toxic effects of substances when they are ingested orally. It focuses on understanding the potential adverse effects that a substance can have on the body after oral exposure. Oral toxicology studies are conducted to determine the toxicity of various substances, including chemicals, drugs, food additives, pesticides, and other orally administered agents. The goal is to assess the safety and potential risks associated with these substances when they are consumed through the mouth. In oral toxicology studies, researchers typically use animal models, such as rodents, to evaluate the effects of substances on various organs and systems in the body. These studies involve administering the substance orally to the animals, usually in different doses, and monitoring them for a specified period. The researchers observe and measure

various parameters, including clinical signs of toxicity, changes in body weight, food consumption, CONNECTDXLABS.COM

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

organ weights, blood and biochemical parameters, histopathological changes in tissues, and other relevant endpoints. By examining these parameters, toxicologists can determine the potential toxic effects of the substance and establish dose-response relationships. Oral toxicology studies provide crucial data for regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), to assess the safety of substances intended for human consumption. The results of these studies help inform the establishment of safe exposure limits, the determination of appropriate warning labels or contraindications, and the identification of potential health hazards associated with oral exposure to substances.

It's worth noting that in recent years, there has been a growing interest in alternative methods to reduce reliance on animal testing in toxicology, including the development and application of in vitro models and computational toxicology approaches. These alternatives aim to improve the efficiency, predictability, and ethical considerations of oral toxicity testing while still ensuring human safety.

O ur mission is to offer superior and innovative testing services that meet the needs of the providers in our communities, while leading the way for operational excellence through honesty and integrity.

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a y

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

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I nfectious diseases are illnesses caused by pathogenic microorganisms, such as bacteria, viruses, fungi, or parasites, that can be transmitted from person to person or from animals to humans. These diseases can range from mild to severe and can affect various systems and organs in the body. There are numerous infectious diseases that affect humans, and they can be classified based on the type of microorganism involved and the mode of transmission. Some examples of infectious diseases include: 1. Bacterial Infections: Examples include tuberculosis, strep throat, urinary tract infections, Lyme disease, and pneumonia caused by bacteria such as Staphylococcus, Streptococcus, 1.

Escherichia coli (E. coli), and Mycobacterium tuberculosis. 2. Viral Infections: Examples include influenza, common cold, HIV/AIDS, hepatitis, measles, mumps, rubella, herpes, and COVID-19. Viruses such as influenza viruses, rhinoviruses, coronaviruses, human immunodeficiency virus (HIV), hepatitis viruses, and herpesviruses are responsible for these diseases. 3. Fungal Infections: Examples include 3. 2.

candidiasis, ringworm, athlete's foot, and fungal pneumonia. Fungi like Candida, Aspergillus, and dermatophytes can cause these infections. 4. Parasitic Infections: Examples include malaria, giardiasis, toxoplasmosis, 4. and schistosomiasis. Parasites such as Plasmodium, Giardia, Toxoplasma, and Schistosoma can cause these diseases.

Respiratory Infectious Diseases respiratory viruses like influenza, respiratory syncytial virus (RSV), and SARS-CoV-2 (COVID-19). 2. Antigen Detection Tests: Antigen tests detect specific proteins or antigens present on the surface of pathogens. These tests are rapid and provide quick results. Antigen tests are commonly used for diagnosing respiratory viruses such as influenza and RSV. 3. Antibody Testing: Serological tests detect antibodies produced by the immune system in response to an infection. Blood samples are collected to check for the presence of specific antibodies, indicating past or recent respiratory infections. Antibody tests are commonly used for respiratory diseases like COVID-19 or Mycoplasma pneumoniae infections. 4. Susceptibility Testing: In cases of bacterial respiratory infections, susceptibility testing is performed to 2. 3.

I n a laboratory setting, various tests can be performed to diagnose respiratory infectious diseases. These tests are typically conducted on samples collected from the respiratory system, such as nasal swabs, throat swabs, sputum, or bronchoalveolar lavage (BAL) fluid. Here are some common laboratory tests used for respiratory infectious disease testing: Microbiological Culture: Samples, such as swabs or sputum, are cultured on specific growth media to identify and grow bacteria or fungi causing respiratory infections. The cultured organisms are then analyzed for their characteristics and sensitivity to antimicrobial agents. 1. Molecular Testing: Polymerase Chain Reaction (PCR) and other molecular techniques can detect the genetic material (DNA or RNA) of pathogens. These tests are highly sensitive and specific, allowing for the identification of viruses, bacteria, and fungi causing respiratory infections. PCR-based tests are commonly used for diagnosing 1.

determine the sensitivity of the isolated pathogen to various antimicrobial agents. This helps guide appropriate antibiotic therapy. 5. Histopathological Examination: Lung tissue samples obtained through procedures like biopsies or autopsies are examined microscopically to detect the presence of infectious agents and evaluate the inflammatory response in the respiratory system. It’s important to note that the specific 5. tests used may vary depending on the suspected respiratory infection, clinical presentation, and available laboratory resources. Healthcare professionals and laboratory technicians follow established protocols and guidelines for specimen collection, processing, and testing to ensure accurate and reliable results. The

interpretation of test results should be done by trained healthcare professionals to guide diagnosis and treatment decisions.

I t is our goal to be a trusted resource for healthcare providers and offer testing solutions that improve patient outcomes .

A COVID PCR (Polymerase Chain Reaction) test is a diagnostic test used to detect the presence of the SARS-CoV-2 virus, which causes COVID-19. It is considered one of the most reliable and accurate methods for diagnosing an active COVID-19 infection. The PCR test works by amplifying the genetic material (RNA) of the virus

present in a patient's sample, typically collected from the nasal or throat swab. Here's a general overview of the process: 1. Sample collection: A healthcare professional collects a nasal or throat swab from the patient. The swab collects cells and secretions from the respiratory system that may contain the virus. 2. RNA extraction: The collected sample is processed in a 1. 2.

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laboratory to extract the viral RNA. This step involves breaking open the virus particles and isolating the RNA. 3. Reverse transcription: The extracted viral RNA is converted into complementary DNA (cDNA) using an enzyme called reverse transcriptase. This step allows for easier amplification of the viral genetic material. 4. PCR amplification: The cDNA is mixed with specific primers, DNA polymerase, and nucleotides in a process called PCR amplification. The primers are designed to target specific regions of the SARS- CoV-2 genome. The DNA polymerase enzyme amplifies the targeted viral genetic material through a series of heating and cooling cycles, creating millions of copies of the viral DNA. 5. Detection: The PCR amplification is monitored in real-time using fluorescent probes or dyes. If the virus is present in the patient's sample, the fluorescence signal will increase during the amplification cycles, indicating a positive result. If the virus is not present, there will be no significant increase in fluorescence, indicating a negative result. 4. 3. 5.

The result of a COVID PCR test is typically reported as positive or negative for SARS-CoV-2 infection. The test can be highly sensitive, detecting even small amounts of viral genetic material. However, it's important to note that a negative PCR test does not completely rule out COVID-19, especially if the test is performed during the early stages of infection or if the sample is not collected properly. COVID PCR tests are widely used for diagnostic purposes, contact tracing, surveillance, and monitoring the spread of the virus. They are typically performed in laboratories or clinical settings with specialized equipment and trained personnel. Rapid PCR tests with shorter turnaround times are also available in some settings, allowing for quicker results. CONTACT US TODAY: 236 W. Edison Rd Mishawaka, IN 46545 (800) 450-0040

CONNECTDXLABS.COM W e offer testing solutions for • toxicology ( oral / urine )

• infectious diseases • pharmacogenetics

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

infectious disease testing in women

I n a laboratory, various tests can be performed to diagnose infectious diseases in women. These tests aim to identify the presence of specific pathogens responsible for the infection. The specific tests performed may vary depending on the suspected infection, clinical presentation, and available laboratory resources. Here are some common laboratory tests used for infectious disease testing in women: 1. Microbiological Culture: Samples, such as vaginal swabs, cervical swabs, or endocervical specimens, are cultured on specific growth media to identify and grow bacteria, fungi, or other pathogens causing infections like bacterial vaginosis, urinary tract infections, or sexually transmitted infections (STIs). The cultured organisms are then analyzed for their characteristics and susceptibility to antimicrobial agents. 2. Nucleic Acid Amplification Tests (NAATs): These molecular tests detect the genetic material (DNA or RNA) of specific pathogens. NAATs are highly sensitive and specific, allowing for the identification of sexually transmitted infections such as Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and human papillomavirus (HPV). Samples for 2. 1.

NAATs can be collected from vaginal swabs, cervical swabs, urine samples, or other relevant sites.

3. Serological Testing:

Serological tests detect specific antibodies produced by the immune system in response to an infection. Blood

samples are collected to check for the presence of antibodies, indicating past or current infections. Serological tests are commonly used for infections like syphilis, HIV, hepatitis B, and hepatitis C. 4. Antigen Detection Tests: Antigen tests detect specific proteins or antigens present on the surface of pathogens. These tests are rapid and provide quick results. Antigen tests are commonly used for diagnosing certain STIs, such as herpes simplex virus (HSV) or HIV. 5. Pap Test (Pap Smear): The Pap test is primarily used for cervical cancer screening 5. 4.

but can also detect the presence of abnormal cells caused by certain infections, such as human papillomavirus (HPV). During a Pap test, cells are collected from the cervix and examined under a microscope for any abnormalities. 6. Histopathological Examination: Biopsy samples obtained from the cervix or other affected sites may be examined microscopically to detect the 6.

presence of infectious agents, assess tissue changes, and evaluate the severity of infection-related abnormalities. It’s important to note that the

choice of tests depends on the specific infection being investigated, clinical indications, and laboratory capabilities. Healthcare professionals and laboratory technicians follow established protocols and guidelines for specimen collection, processing, and testing to ensure accurate and reliable results. The interpretation of test results should be done by trained healthcare professionals to guide diagnosis, treatment, and appropriate management of infectious diseases in women.

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U nder the oversight of our leadership team, our highly skilled technicians operate in a modern digital lab to handle everything from carrying out routine diagnostic tests and screenings, to providing an accurate and valuable result to assist you in creating treatment plans for complex illnesses.

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

I n a laboratory, several tests can be performed to diagnose urinary tract infections (UTIs). These tests help identify the presence of bacteria or other pathogens in the urinary tract. Here are some common laboratory tests used for UTI testing: 1. Urine Culture: This is the gold standard test for diagnosing UTIs. A urine sample is collected, and it is cultured on specific growth media to allow the growth and identification of bacteria or fungi causing the infection. The cultured organisms are then analyzed for their characteristics and susceptibility to antibiotics. 2. Urine Microscopy: A urine 2. sample is examined under a microscope to look for the presence of bacteria, white blood cells (indicating inflammation and infection), red blood cells (indicating possible kidney or bladder damage), and other abnormalities. 1.

UTI TESTING

3. Urine Dipstick Test: A dipstick is dipped into a urine sample, and it provides immediate results for certain parameters such as nitrites (produced by some bacteria), leukocyte esterase (indicating the presence of white blood cells), and blood in the urine. 4. Antibiotic Sensitivity Testing: If bacteria are isolated from a urine culture, antibiotic sensitivity testing is performed to determine the most effective antibiotics for treating the infection. This helps guide appropriate antibiotic therapy. 5. Polymerase Chain Reaction 5. (PCR): PCR-based tests can detect the genetic material (DNA or RNA) of specific pathogens causing UTIs, such as Escherichia coli or other bacteria. These tests are highly sensitive and specific and can provide rapid results. 4.

6. Imaging Tests: In some cases, imaging tests such as ultrasound, CT scan, or MRI may be performed to evaluate the urinary tract for any structural abnormalities or complications associated with UTIs, such as kidney stones or urinary tract obstruction. The choice of test depends on factors such as the patient's symptoms, medical history, and severity of the infection. Healthcare professionals and laboratory technicians follow established protocols and guidelines for specimen collection,

processing, and testing to ensure accurate and reliable results. The interpretation of test results should be done by trained healthcare professionals to guide diagnosis and appropriate treatment of UTIs. CONNECTDXLABS.COM

Cardiovascular pharmacogenetics testing

C ardiovascular pharmacogenetics testing involves analyzing an individual’s genetic makeup to assess how their genetic variations may influence their response to cardiovascular medications. This type of testing aims to personalize drug selection, dosage, and treatment plans to maximize therapeutic efficacy and minimize adverse effects. Here’s an overview of cardiovascular pharmacogenetics testing: 1. Genetic Variants: Genetic variations, such as single nucleotide polymorphisms (SNPs), can impact drug metabolism, transport, and target interactions. By analyzing specific genetic variants associated with cardiovascular drug response, pharmacogenetics testing can provide insights into an individual’s unique genetic profile. 2. Drug Metabolism: Some genetic variations affect the activity of drug-metabolizing enzymes, such as cytochrome P450 (CYP) enzymes. These enzymes are responsible for metabolizing many cardiovascular medications. Pharmacogenetics testing can identify genetic variants that influence enzyme activity and provide information about how an individual may metabolize specific drugs. 3. Drug Transporters: Genetic variations in drug transporter proteins, such as P-glycoprotein (P-gp), can impact the distribution and elimination of cardiovascular drugs. 3. 1. 2.

Pharmacogenetics testing can assess genetic variants in drug transporter genes, helping predict an individual’s response to drugs that are substrates of these transporters. 4. Drug Targets: Genetic variations in drug target proteins, such as beta-adrenergic receptors or angiotensin-converting enzyme, can affect the binding affinity or response to certain cardiovascular drugs. Pharmacogenetics testing can provide information about genetic variants that may influence drug efficacy or susceptibility to adverse effects. 5. Treatment Optimization: By integrating genetic information with clinical data, pharmacogenetics testing can help guide treatment decisions. It can inform drug selection, dosing adjustments, and personalized treatment plans based on an individual’s genetic profile and predicted drug response. Examples of Cardiovascular Pharmacogenetics Testing: Specific pharmacogenetic tests may include assessing genetic variants related to antiplatelet medications (e.g., clopidogrel), anticoagulants (e.g., warfarin), beta-blockers, ACE inhibitors, calcium channel blockers, or statins. It’s important to note that cardiovascular pharmacogenetics testing is an evolving field, and the specific genetic variants analyzed may vary depending on the testing platform and laboratory protocols. Clinical interpretation of genetic test results should be done by healthcare professionals with expertise in pharmacogenetics to ensure appropriate use of the information for personalized patient care. 4. 5.

SERVICES WE PROVIDE: • Toxicology •Infectious Diseases •Covid PCR • Pharmacogenetics

236 W. Edison Rd, Mishawaka, IN 46545 (800) 450-0040

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P sychiatry pharmacogenetics laboratory testing

(800) 450-0040 236 W. Edison Rd Mishawaka, IN 46545

pharmacogenetics laboratory testing involves the analysis of genetic variations relevant to psychiatric medications in a laboratory setting. The purpose is to provide healthcare providers with genetic information that can guide treatment decisions and improve patient outcomes. Here’s an overview of the process involved in psychiatry pharmacogenetics lab testing: 1. Sample Collection: Typically, a saliva or blood sample is collected from the patient. Saliva samples can be collected using a saliva collection kit, which includes a tube or container for saliva collection. Blood samples are usually collected through a standard venipuncture procedure. 2. DNA Extraction: In the laboratory, the DNA is extracted from the collected sample. This process involves isolating the genetic material (DNA) from the other components of the sample. 3. Genotyping: Once the DNA is extracted, specific genetic variants relevant to psychiatric medications are analyzed. This can be done using different genotyping techniques, such as polymerase chain reaction (PCR), microarray-based genotyping, or next-generation sequencing (NGS) technologies. These techniques detect and analyze specific genetic variations known to impact drug metabolism, receptor interactions, or neurotransmitter pathways relevant to psychiatric medications. 4. Result Analysis: The laboratory analyzes the genotyping results to determine the presence or absence of specific genetic variants associated with psychiatric drug response. These results are then interpreted in the context of established pharmacogenetic guidelines or databases to provide insights into the potential implications for treatment. 5. Report Generation: A comprehensive report is generated based on the genotyping results and their interpretation. The report provides information about the patient’s genetic profile relevant to psychiatric medications, including recommendations on drug selection, dosing considerations, and potential risk factors for adverse effects. 6. Clinical Integration: The laboratory report is shared with the healthcare provider, who uses the information in combination with clinical judgment to make informed treatment decisions. The healthcare provider considers the patient’s genetic profile, clinical presentation, medical history, and other factors to individualize the treatment plan and optimize medication selection and dosing. 1. 2. 3. 4.

I t is our goal to be a trusted resource for healthcare providers and offer testing solutions that improve patient

outcomes. Our mission is to offer superior and innovative testing services that meet the needs

of the providers in our communities, while leading the way for operational excellence through honesty and integrity.

Call us: (800) 450-0040

we provide advanced diagnostic testing for • healthcare providers

• medical facilities • homecare agencies

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